Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Molnupiravir 200mg capsules, (4 x 200mg), twice a day for 5 days before food intake.: Standard of care
Control Intervention1: Standard of Care: Ivermectin 12mg, oral tablet, once daily
Sponsors
NATCO Pharma Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients willing and able to provide voluntary written informed consent and to follow the protocol requirements 2. Male or female patients between 18 and 60 years of age (both inclusive) 3. Patients with positive RT-PCR test for SARS-CoV-2 in nasopharyngeal and/or oropharyngeal swabs (sample collected �5 days prior to randomization) Note: If rapid antigen test has been performed and patient found positive then RT-PCR will be performed prior to randomization 4. Patients with mild COVID-19 and have following symptoms and signs prior to randomization Upper respiratory tract symptoms (&/or fever) without shortness of breath or hypoxia 5. Patients who are able to consume oral medications 6. Males agree to the following during the intervention period and for at least 90 days after the last dose of study intervention: Refrain from donating sperm; and either abstain from sexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent; or must agree to use contraception 7. Females who are not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of child bearing potential (WOCBP); or is a WOCBP and using a contraceptive method that is highly effective (a low user dependency method OR a user dependent method in combination with barrier method), or be abstinent from sexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) for 28 days from the start of study intervention; a WOCBP must have a negative highly sensitive pregnancy test (urine or serum test is required) within 24 hours before the first dose of study intervention
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity or contraindications to any of the components of the study interventions or to any other similar class of drugs as determined by the investigator 2. Uncontrolled comorbid medical conditions 3. SpO2 ââ?°Â¤ 93% on room air and respiratory rate ââ?°Â¥ 24/min and breathlessness 4. Patient is currently hospitalized or is expected to need hospitalization for COVID-19 within 48 hours of randomization 5. Patient is on dialysis or has reduced estimated glomerular filtration rate (eGFR) equation 6. If patient has any of the following conditions: human immunodeficiency virus (HIV); chemotherapy required within 6 weeks before randomization; a neutrophilic granulocyte absolute count 7. If patient has a history of hepatitis B virus (HBV) or hepatitis C virus (HCV) with cirrhosis, end-stage liver disease, hepatocellular carcinoma, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >3X upper limit of normal at screening 8. If patient has a platelet count 9. Patient has a history of acute pancreatitis within 3 months prior to randomization or a history of chronic pancreatitis 10. Patient is currently receiving or anticipated to require any prohibited medications/ therapies (e.g. Favipiravir, Oseltamivir, Remdesivir or any other anti-viral treatments) during study participation as per investigatorââ?¬•s discretion 11. A baseline heart rate of 12. If patient has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments including but not limited to: participants who are not expected to survive longer than 48 hours after randomization, participants who are expected to require mechanical ventilation within 48 hours after randomization, or participants with a recent history of mechanical ventilation, or participants with conditions that could limit gastrointestinal absorption of capsule contents
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Molnupiravir compared to standard of care in confirmed RT-PCR positive patients with mild COVID-19.Timepoint: Rate of hospitalization from randomization up to Day 14. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety of Molnupiravir compared to standard of care in confirmed RT-PCR positive patients with mild COVID-19.Timepoint: 1. Rate of hospitalization from randomization up to Day 28 2. Proportion of patients with clinical improvement at end of treatment, Day 10 and 14 3. Time to clinical improvement from randomization up to Day 14 4. Mortality rate at Day 14 5. Rate of SARS-CoV2 RT-PCR negativity in nasopharyngeal and/or oropharyngeal swab at end of treatment, Day 10 and Day 15 6. Incidence and severity of Treatment Emergent Adverse Events (TEAEs) (clinical and laboratory) during the study | — |
Countries
India
Contacts
Public ContactDr Sandeep Singh
CBCC Global Research LLP
Outcome results
None listed